WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM— 510(k) K953000

Substantially Equivalent

Implant Center of the Palm Beaches

FDA 510(k) clearance K953000 for WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM, Substantially Equivalent on 1995-10-31. Applicant: Implant Center of the Palm Beaches.

Clearance details

Applicant: Implant Center of the Palm Beaches
Product code: Code DZE
Advisory panel: Dental
Date received: 1995-06-23
Decision date: 1995-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Palm Beach, FL, US

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Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.